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510(k) K863913

THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT by Diagnostic Products Corp. — Product Code DOE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1987
Date Received
October 8, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
Device Class
Class II
Regulation Number
862.3640
Review Panel
TX
Submission Type

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  • K951319 — ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 (June 1, 1995)
  • K935055 — ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF) (August 9, 1994)
  • K933572 — URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125) (April 6, 1994)
  • K881102 — MICROMEDIC MORPHINE RIA KIT (June 24, 1988)
  • K864168 — MORPHINE ROCHE (R) EIA TEST (March 16, 1987)
  • K830460 — ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (March 24, 1983)